Devices and Methods for Delivering Fluid to a Nasal Cavity

ABSTRACT

Devices and methods for delivering fluid to the nasal cavity that include a delivery tube and cap configured to be connected to a container that houses the fluid. The delivery tube includes an inner cannula that is positioned within an outer cannula. Each of the cannulas includes a first outlet with one or more openings aligned along a first lateral section and a second outlet with one or more openings aligned along a second lateral section. The cap is configured to secure the delivery tube to the container. The delivery tube and cap are configured to provide relative axial movement between the cannulas. The cannulas are positionable between a first axial position that aligns the first outlets along the first lateral section of the delivery tube to deliver the fluid to a first portion of the nasal cavity, and a second axial position that aligns the second outlets along the second lateral section to deliver fluid to a second portion of the nasal cavity.

TECHNICAL FIELD

The present disclosure relates to devices and methods for deliveringfluid to the nasal cavity, and more particularly to expelling the fluidfrom specific lateral sections of the delivery device to target specificareas of the nasal cavity.

BACKGROUND

The nasal cavity comprises a variety of surfaces that correspond toanatomic structures serving various respective biological functions.Generally, the nasal cavity is divided vertically by a wall of cartilagecalled the septum. On each side of the septum is a nostril through whichthe nasal cavity can be accessed. Opposite the septum, on each lateralside of the nasal cavity, are a series of turbinates (also known asconcha). Each series comprises an inferior, middle, and superiorturbinate, as one goes in a posterior direction from the nostrils,through the nasal cavity, towards the throat. These turbinates are aseries of bony ridges that protrude into the nasal cavity. Themaxillary, anterior ethmoid, and frontal sinuses drain into the nasalcavity from under the middle turbinate, which is above the inferiorturbinate.

In order to treat these anatomic structures within the nose, therapeuticfluids can be topically applied to their corresponding surfaces. Suchfluids for example, include saline, antihistamines, decongestants, andcorticosteroids, which may be helpful in irrigating nasal passages,treating allergies, relieving nasal congestion, and treatinginflammation, respectively. To deliver these fluids to various surfacesin the nasal cavity, a spray bottle is often used. To use the spraybottle, a patient typically inserts a nozzle through their nostril andejects fluid from the nozzle in a haphazard and indiscriminate fashion.While haphazardly and indiscriminately dispensing fluid in this fashiontends to result in at least some fluid being applied to an appropriatesurface within the nasal cavity, such an approach is inefficient atbest. Indeed, a large percentage of the fluid delivered by this methodis often wasted by being applied to surfaces for which the fluid candeliver little to no therapeutic value.

SUMMARY

The present application is directed to devices that deliver fluid to anasal cavity. The device may be configured to deliver the fluidpredominantly and/or entirely from one lateral section. The device maybe adjustable to deliver the fluid to the desired lateral section asneeded for delivery fluid to the different sections of the nasal cavity.The device is further configured to be attached to a container thathouses the fluid.

One embodiment is directed to a device to deliver fluid from a containerto a nasal cavity. The device includes a hollow inner cannula with aninlet at a proximal end and first and second outlets positioned towardsa distal end with the first and second outlets on different lateralsections. The inlet and the first and second outlets are in fluid-flowrelationship. A hollow outer cannula extends over and houses the innercannula. The outer cannula includes third and fourth outlets towards adistal end with the third and fourth outlets being on different lateralsections of the outer cannula. A cap is connected to each of the innerand outer cannulas and configured to provide relative axial movement ofthe inner and outer cannulas along a longitudinal axis of the cannulasbetween a first axial position and a second axial position. In the firstaxial position, the first and third outlets are aligned and the secondand fourth outlets are misaligned thereby permitting the fluid to bepredominantly ejected from the third outlet via the first outletrelative to the fourth outlet via the second outlet. In the second axialposition, the first and third outlets are misaligned and the second andfourth outlets are aligned thereby permitting the fluid to bepredominantly ejected from the fourth outlet via the second outletrelative to the third outlet via the first outlet.

The device may also include a first section that is attached to theproximal end of the inner cannula, and a second section that isrotatable relative to the first section and that includes first andsecond ramps that engage with the outer cannula. The first and secondsections may be rotatable relative to each other in a clockwisedirection to slide the outer cannula along the first ramp and move theouter cannula axially relative to the inner cannula in a firstdirection. The first and second sections may be rotatable relative toeach other in a counter-clockwise direction to slide the outer cannulaaxially relative to the inner cannula in an opposing second direction.

The inner cannula may be fixedly attached to the first section of thecap to prevent movement of the inner cannula during movement of theouter cannula.

The device may include fins that extend radially outward from the outercannula and engage with first and second ramps of the second section.

The device may include that each of the first, second, third, and fourthoutlets include a plurality of openings.

The first and third outlets may include a common number of openings andthe second and fourth outlets may include a common number of openings.

The device may also include an opening in the distal end of each of theinner and outer cannulas.

Another embodiment is directed to a device to deliver fluid from acontainer to a nasal cavity. The device includes a delivery tube withinner and outer cannulas with the inner cannula positioned within ahollow interior of the outer cannula. Each of the cannulas includes anelongated shape with a proximal end and an opposing distal end, a firstoutlet towards the distal end and positioned on a first lateral section,and a second outlet towards the distal end and positioned on a secondlateral section. A cap is connected to each of the inner and outercannulas and configured to axially position the inner and outer cannulasrelative to one another between a first axial position and a secondaxial position. The first axial position includes the first outletsaligned at the first lateral section of the delivery tube and the secondoutlets misaligned at the second lateral section of the delivery tube todeliver the fluid in a first lateral direction. The second axialposition includes the second outlets aligned at the second lateralsection of the delivery tube and the first outlets misaligned at thefirst lateral section of the delivery tube to deliver the fluid in asecond lateral direction.

The device may include that the proximal ends of each of the inner andouter cannulas may be connected to the cap.

The device may include that one of the inner cannula and the outercannula are threaded onto a threaded portion of the cap.

The device may include that the first axial position the second outletsmay overlap a lesser amount than the first outlets such that apredominant amount of the fluid is ejected from the delivery tube in thefirst lateral direction and a lesser amount of the fluid is ejected fromthe delivery tube in the second lateral direction.

The device may include that the first outlets and the second outlets ofeach of the inner and outer cannulas may be spaced apart around theperimeter of the cannulas by an angle of 90° or less.

The cap may include a plurality of members that each include an openingwith the members being rotatably connected together and with theopenings coaxially aligned.

The device may include that the inner cannula may be fixedly connectedto the cap and the outer cannula may be movable relative to the cap withthe inner cannula being stationary during movement of the outer cannula.

Another embodiment is directed to a method of delivering fluid from acontainer to a nasal cavity. The method includes: rotating a first capmember in a first rotational direction relative to a second cap memberwith a delivery tube with an inner cannula and an outer cannula beingconnected to the first and second cap members; relatively moving theouter cannula relative to the inner cannula in a first axial direction;aligning a first set of outlets on a first lateral section of the innerand outer cannulas and misaligning a second set of outlets on a secondlateral side of the inner and outer cannulas with the outlets beingpositioned towards distal ends of the inner and outer cannulas; movingthe fluid from the container into a proximal end of the inner cannula atthe first and second cap members and along the inner cannula andexpelling the fluid through the aligned first set of outlets on thefirst lateral section; rotating the first cap member in a secondrotational direction relative to the second cap member; relativelymoving the outer cannula relative to an inner cannula in an opposingsecond axial direction; aligning the second set of outlets on the secondlateral section of the inner and outer cannulas and misaligning thefirst set of outlets on the first lateral side of the inner and outercannulas; moving the fluid into the proximal end of the inner cannula atthe first and second cap members and along the inner cannula andexpelling the fluid through the aligned second set of outlets on thesecond lateral section.

The method may further include preventing the inner cannula from movingrelative to the first and second cap members and moving the outercannula axially along the inner cannula.

The method may further include moving the outer cannula relative to theinner cannula in the first and second axial directions andsimultaneously rotating the outer cannula relative to the inner cannula.

The method may further include expelling a lesser amount of the fluidthrough the misaligned second set of outlets on the second lateralsection of the delivery tube when expelling the fluid through thealigned first set of outlets on the first lateral side.

The method may further include moving a body of the outer cannula overthe outlet on the second lateral section of the inner cannula andpreventing the fluid from being expelled on the second lateral sectionwhen the fluid is being expelled on the first lateral side through thealigned first second of outlets.

The various aspects of the various embodiments may be used alone or inany combination, as is desired.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a delivery device connected to acontainer.

FIG. 2 is an exploded perspective view of a delivery device and acontainer.

FIG. 3 is a perspective view of a delivery tube with an outer cannulaextending over and housing an inner cannula;

FIG. 4 is a schematic section view of the outer cannula at an axialposition relative to an inner cannula to deliver fluid in a firstlateral direction.

FIG. 5 is a schematic section view of the outer cannula at an axialposition relative to an inner cannula to deliver fluid in a secondlateral direction.

FIG. 6 is a perspective view of a lower portion of a base cap.

FIG. 7 is a perspective view of a lower portion of an intermediate cap.

FIG. 8 is a perspective view of an upper portion of an intermediate cap.

FIG. 9 is a perspective view of a base cap and an intermediate capassembled together and a delivery tube extending outward therefrom.

FIG. 10 is a perspective view of an upper portion of a top cap.

FIG. 11 is a perspective view of a lower portion of a top cap.

FIG. 12 is a perspective view of a delivery device in a first positionand attached to a container.

FIG. 13 is a perspective view of a delivery device in a second positionand attached to a container.

FIG. 14A is a schematic view of angular orientations between first andsecond outlets of an outer cannula.

FIG. 14B is a schematic view of angular orientations between first andsecond outlets of an outer cannula.

DETAILED DESCRIPTION

The present application is directed to devices and methods fordelivering fluid from a container to the nasal cavity. One deviceincludes a delivery tube and cap configured to be connected to acontainer that houses the fluid. The delivery tube includes an innercannula that is positioned within an outer cannula. Each of the cannulasincludes a first outlet with one or more openings aligned along a firstlateral section and a second outlet with one or more openings alignedalong a second lateral section. The cap is configured to secure thedelivery tube to the container. The delivery tube and cap are configuredto provide relative axial movement between the cannulas. The cannulasare positionable between a first axial position that aligns the firstoutlets along the first lateral section of the delivery tube to deliverthe fluid to a first portion of the nasal cavity, and a second axialposition that aligns the second outlets along the second lateral sectionto deliver fluid to a second portion of the nasal cavity.

The fluids that are delivered in accordance with aspects of the presentdisclosure may be made by dissolving a tablet in a predetermined amountof distilled water. According to one aspect of the present disclosure, atablet is provided for ease of use as opposed to powder form, which hasbeen determined to be both cumbersome and otherwise overly reliant onthe expertise of a particular user/consumer. Such tablets arecontemplated as being provided to a user in the form of a solutionpreparation kit. In one alternate aspect, a solution may be included ina kit, however, the tablet form may increase ease, precision, and extendthe shelf life of the kit, according to particular embodiments.

Examples of preparation for the tablets as may be included in the kitare provided below. The tablets may further comprise amounts of buffers,dissolving agents, complexing agents, and the like that would notinterfere with the desired and predetermined parameters stated in Table1 below. In other words, the tablets may comprise additional non-listedcompounds that would not affect desired predetermined pH values,dissolving time, overall tablet weight, and/or other desirable factors.

In a particular example, a tablet was made for use in preparing asolution/rinse for irrigating a nasal cavity according to an aspect ofthe present disclosure. An amount of sodium chloride (120 mg); sodiumbicarbonate (290 mg); and citric acid (40 mg) was combined with the useof a mortar and pestle. The resulting mixture was molded into a 450 mgtablet via use of a hydraulic press (Kahan Analytical Solutions, Dehli,India). The press applied a pressure equal to 7 tons/m² at a temperatureof 25° C. The tablet was then dried for at least five seconds at atemperature of 25° C.

A solution was prepared using the tablet made as described above. Thetablet was dissolved in 100 ml of distilled water having a temperatureof 40° C. (104° F.). The tablet dissolved substantially completelywithin about 30 sec. The resulting solution (after tablet dissolution)had a pH of about 6.98. A non-exhaustive listing of other useful tabletcompositions made and tested for tableting compounds for use inpreparing solutions used according to aspects of the present disclosureare provided below in Table 1.

TABLE 1 Sodium Sodium Citric Tablet Dissolution Dissolution CapsuleChloride (mg) bicarbonate (mg) Acid (mg) wt. (mg) pH time (sec) Vol.(ml) NaCl 120 290 40 450 6.98 20 132 Mupirocin 120 290 40 465 6.71 21132 Budesonide + 120 290 40 465.5 6.42 10 132 mupirocin (15.6 mg)Budesonide 120 290 40 450.6 6.21 31 132 (0.6 mg)

The fluid is delivered to the nasal cavity by a delivery device 10. Forexample, FIG. 1 illustrates a device 10 connected to a container 100.The device 10 includes a delivery tube 20 sized to be inserted into theuser's nasal cavity. The device 10 also includes a cap 40 that connectsthe delivery tube 20 to the container 100. The cap 40 is movable toadjust the delivery tube 20 to selectively deliver the fluid in thecontainer 100 to selected portions of the nasal cavity.

FIG. 2 illustrates an exploded view of a device 10 and a container 100.The delivery tube 20 is constructed from an outer cannula 21 and aninner cannula 31. The cannulas 21, 31 are configured to move axiallyrelative to one another to provide for selective delivery of the fluidinto the nasal cavity. The cap 40 is constructed from a base cap 50, anintermediate cap 60, and a top cap 70. The cap 40 is configured to beremovably attached to the container 100.

FIG. 3 illustrates the delivery tube 20 with the inner cannula 31positioned within the outer cannula 21. The delivery tube 20 may includea curving centerline along a geometric plane 110 that for purposes ofexplanation divides the delivery tube 20 into first and second lateralsections. The delivery tube 20 may also include other shapes asnecessary to deliver the fluid to the nasal cavity, including but notlimited to a straight shape. The lateral sections of the delivery tube20 may be separated by different amounts of angular separation aroundthe delivery tube 20. One design includes the lateral sections being onopposing sides of the delivery tube 20 (i.e., 180° apart). Other designsfeature a small angular separation that is 90° or less. Other designsfeature between 90°-180°.

The delivery tube 20 and the cap 40 may be constructed from variousmaterials, including but not limited to plastics and rubber. Thecannulas 21, 31 may be flexible to facilitate insertion into the nasalcavity and prevent possible injury to the user with the cap 40 beingconstructed from more rigid materials. The cannulas 21, 31 may beconstructed from the same or different materials. FIG. 2 includes anembodiment with the outer cannula 21 constructed from a stiffer materialthan the inner cannula 31. The stiffer construction provides for theouter cannula 21 to have a curved shape. The more flexible inner cannula31 assumes this shape when inserted into the outer cannula 21.

As illustrated in FIGS. 2 and 3, the outer cannula 21 includes anelongated body 22 with a proximal end 23 and an opposing distal end 24.The proximal end 23 is open and leads into a hollow interior thatextends the length of the body 22. One or more fins 27 are positionedtowards the proximal end 23. One design includes two fins 27 that extendradially outward on opposing sides of the body 22. Other designs includea different number of fins 27 and/or different angular arrangements.

Outlets 28 are positioned towards the distal end 24 of the body 22. Theoutlets 28 are positioned on different lateral sections of the body 22to dispel the liquid in different lateral directions. Each outlet 28includes one or more openings 25. The openings 25 of each outlet 28 maybe aligned in a longitudinal column along the body 22. Other designsinclude the openings 25 being offset at different angular orientationsalong the body 22. The different outlets 28 may include the same ordifferent number of openings 25, and the openings 25 may have the sameor different shapes and/or sizes.

The distal end 24 of the outer cannula 21 may be closed to prevent theejection of fluid. Another design includes the distal end 24 having anopening to dispel fluid outwardly and into the nasal cavity.

The inner cannula 31 is sized to fit within the hollow interior of theouter cannula 21. The inner cannula 31 includes an elongated body 32with a proximal end 33 and an opposing distal end 34. The proximal end33 is open and leads into a hollow interior that extends the length ofthe body 32. The distal end 34 may be closed or open depending uponwhether fluid is to be ejected outward in the distal direction. Theinner cannula 31 also includes a flange 36 in proximity to the proximalend 33. The flange 36 has a larger diameter than the remainder of thebody 32 and provides for securing the inner cannula 31 in the cap 40.

Outlets 38 each with one or more openings 35 are positioned on differentlateral sections of the body 32 in proximity to the distal end 34. Theopenings 35 in the outlets 38 may be aligned in a longitudinal column,or may have an angular offset between openings 35. The outlets 38 mayhave the same or a different number of openings 35 and may have the sameor different shapes and/or sizes. In one design, each of the inner andouter cannulas 21, 31 includes two outlets 28, 38. Other designs mayinclude a single outlet 28, 38 on one or both cannulas 21, 31, or threeor more outlets 28, 38 on one or both cannulas 21, 31.

The outer cannula 21 includes a larger sectional size than the innercannula 31. This provides for relative axial movement between thecannulas 21, 31. In one design, the cannulas 21, 31 include the samesectional shape with one specific design including each having acircular section shape. Other designs may include different sectionalshapes, provided the sizing allows for relative axial movement betweenthe cannulas 21, 31. In one design, the relative axial movement occursby the outer cannula 21 moving relative to the stationary inner cannula31. Other designs include an axially movable inner cannula 31 andstationary outer cannula 21, and movable inner and outer cannulas 21,31.

The cannulas 21, 31 are configured to axially move relative to eachother to position the outlets 28, 38 to control the direction that fluidis expelled from the delivery tube 20. FIG. 4 illustrates the cannulas21, 31 at a relative axial position with the inner cannula 31 positionedwithin the hollow interior of the outer cannula 21. In this axialposition, the inner cannula 31 is positioned within the outer cannula 21such that the openings 25 of one of the outlets 28 of the outer cannula21 is aligned with the openings 35 of one of the outlets 38 of the innercannula 31 along one lateral section of the delivery tube 20. As viewedin FIG. 4, the openings 25, 35 are aligned along the left of thedelivery tube 20. This provides for fluid that is moved through thedelivery tube 20 to be expelled in this lateral direction. The openings35 of the outlet 38 of the inner cannula 31 on the opposing lateralsection are aligned with the body 22 of the outer cannula 21. Thisblocks the openings 35 of the outlet 38 thus preventing fluid from beingexpelled from the delivery tube 20 in this lateral direction.

In one design, the openings 35 of the outlet 38 may be partially alignedwith the openings 25 of the outlet 28 on this opposing lateral section.This provides for some of the fluid to be ejected in this second lateraldirection, although substantially more fluid is ejected through thealigned outlets 28, 38 on the first lateral section.

FIG. 5 illustrates an axial position in which the inner and outercannulas 21, 31 have axially moved relative to one another. Thismovement locates the openings 35 of outlet 38 along the opposing lateralsection of the inner cannula 31 with the corresponding openings 25 ofoutlet 28 of the outer cannula 21. This provides for expelling the fluidin this lateral direction. This axial position further blocks the fluidfrom being expelled in the opposing lateral direction as the openings 35of the outlet 38 are aligned with the body 22 of the outer cannula 21.Also, the design may also provide for a smaller amount of fluid to beexpelled from this blocked lateral section as the outlets 28, 38 mayhave some overlap.

FIGS. 4 and 5 include designs in which fluid can be expelled completelyor predominantly from just one lateral sections of the delivery tube 20.The cannulas 20, 30 may be configured with the openings 25, 35 sizedand/or positioned to provide for expelling different amounts of fluid onthe different lateral sections. By way of example, in a particularrelative axial position, the size of the overlapped openings 25, 35 ofthe outlets 28, 38 on a first lateral section may be a first amount toprovide for a first amount of fluid to be expelled, and the overlappingopenings 25, 35 on the second lateral section is smaller or larger suchthat a different amount of fluid is expelled. This design provides forthe user and/or manufacturer to control the amount and direction offluid as necessary.

The delivery tube 20 may also be positioned in a closed position inwhich the outlets 25, 35 are not aligned along either lateral section.This may be used for storage or when the device 10 is not in use.

The cannulas 21, 31 are connected to the cap 40 to provide for the userto adjust the relative axial positioning as necessary. The cap 40 may beconfigured to prevent movement of one of the cannulas 21, 31, andprovide for movement of the other cannula 21, 31 for the different axialpositions. The cap 40 may also be configured to allow movement of eachof the cannulas 21, 31 to provide for the positioning. In one design,the cap 40 maintains the inner cannula 31 stationary and provides foraxial movement of just the outer cannula 21.

The cap 40 includes multiple members that are movable relative to oneanother. Relative movement of the cap members in a first directionprovides for moving one of the cannulas 21, 31 relative to the other ina first axial direction. Relative movement of the cap members in asecond direction provides relative axial movement of the cannulas 21, 31in a second direction.

In one design, the cap 40 comprises three members that provide for therelative movement. This includes a base cap 50, an intermediate cap 60,and a top cap 70.

FIG. 6 illustrates a bottom side of the base cap 50 that attaches to thecontainer 100 (FIG. 2 illustrates a top side of the base cap 50). Thebase cap 50 includes a concave body 51 with an open bottom 58 and aclosed top 59. An opening 52 extends through the body 51 from the bottom58 to the top 59. The interior of the body 51 at the bottom 58 includesthreads to engage with corresponding threads on the container 100 tosecure the base cap 50. The body 51 is configured to mount a tube (notillustrated) at the bottom 58 such that the tube is aligned with theopening 52 and extends into the interior of the container 100. A fitting56 extends around the opening 52 and may include a conical shape withone or more flanges configured to fit within an end of the tube. The top59 of the base cap 50 includes a neck 53 that extends outward from thebody 51 at the opening 52. A slot 54 may be cut across the neck 53. Anopening 57 extends through the base cap 50. The opening 57 may bepositioned in proximity to the opening 52 as illustrated in FIG. 6.

The inner cannula 31 mates with the base cap 50. In one design, theinner cannula 31 is inserted from the bottom 58 through the opening 52of the base cap 50. The opening 52 is sized such that the flange 36towards the proximal end 33 of the inner cannula 31 engages with fitting56 and prevents the cannula 31 from being completely pulled through thebase cap 50. Another design includes the base cap 50 having a receptacleat the opening 52 to receive and secure the proximal end 33 of the innercannula 31 via a press-fit engagement.

The intermediate cap 60 is positioned over the base cap 50. FIG. 7illustrates a bottom view of the intermediate cap 60 and FIG. 8illustrates a top view. The intermediate cap 60 includes a body 61 witha concave shape with an open bottom 68 and a closed top 69. The body 61includes an outer wall 98 that extends around and forms a cavity sizedto receive the base cap 50. A handle 99 is formed by the outer wall 98to rotate the intermediate cap 60 as will be explained below. An opening62 extends through a central point of the body 61 from the bottom 68 tothe top 69. The opening 62 is sized to receive the neck 53 of the basecap 50. The body 61 also includes a neck 96 that extends upward from atop of the cap 60. The cap 60 also includes additional openings 97 inthe body 61 that are positioned in proximity to the central opening 62.

Ramps 63, 64 are positioned along the inner side of the neck 96 at theopening 62. The first ramp 63 extends around a portion of the first sideof the opening 62, and the second ramp 64 extends around a portion onthe opposing second side of the opening 62. Each of the ramps 63, 64includes a contact surface that contact with one of the fins 27 on theouter cannula 21. One of the ramps 63, 64 is positioned to contactagainst a bottom edge of one of the fins 27. The opposing ramp 63, 64 ispositioned to contact against a top edge of the opposing fin 27.Further, the first ramp 63 is angled in a first direction to push thecontacted fin 27 either up or down during rotation of the intermediatecap 60. The second ramp 64 is angled in an opposite direction to pushthe contacted fin in the opposite direction during rotation of the cap60. In one embodiment, ramp 63 is angled to push the fin 27 upward whenthe intermediate cap 60 is rotated clockwise and the second ramp 64 isconfigured to push the contacted fin 27 downward when the intermediatecap 60 is rotated counterclockwise.

As illustrated in FIG. 8, the neck 96 of the intermediate cap 60includes a slot 95 that is in communication with the central opening 62.The slot 95 provides for insertion of the fins 27 of the outer cannula21 during assembly.

FIG. 9 illustrates the base cap 50 and the intermediate cap 60 fittedtogether. The caps 50, 60 are connected together to provide for relativerotation between the two members. The neck 53 of the base cap 50 extendsthrough the opening 62 of the intermediate cap 60 and is positionedwithin the neck 96 of the intermediate cap 60. The fins 27 (notillustrated) of the outer cannula 21 are positioned at the ramps 63, 64(not illustrated). The delivery tube 20 extends outward from the caps50, 60 and is aligned with the openings 52, 62.

The openings 97 of the intermediate cap 60 are positioned above the topof the base cap 50. During relative rotation between the intermediatecap 60 and the base cap 50, one of the openings 97 aligns with theopening 57 in the base cap 50. This provides for air flow into thecontainer 100 after the fluid is expelled through the delivery tube 20.This prevents an air lock from occurring which could prevent or limitthe amount of fluid that is delivered through the delivery tube 20and/or increase the amount of time necessary between fluid expulsionprocedures.

The top cap 70 as illustrated in FIGS. 10 and 11 is sized to extend overthe intermediate cap 60. The top cap 70 includes a concave body 71 witha central opening 72 sized to receive the delivery tube 20. A bottomedge 94 of the body 71 is sized to engage with the intermediate cap 60and/or the base cap 50. A window 93 is positioned at the bottom edge 94along one portion of the body 71 to receive the handle 99 as will beexplained below.

Assembly of the cap 40 may initially include attaching the delivery tube20 to the base cap 50. In one design, the inner cannula 31 is insertedthrough the opening 52 from the bottom side of the cap 50. The innercannula 31 is inserted through the opening 52 until the ridge 36 abutsagainst the fitting 56 that extends downward from the base cap 50 at theopening 52. In this position, the cannula 31 extends through the basecap 50 and the distal end 34 is spaced upward above the base cap 50.

Once positioned, a tube may be attached to the fitting 56 on the bottomof the base cap 50 at the opening 52. The tube may extend over ridges onthe fitting 56 and extend downward from the base cap 50 to be positionedwithin the interior of the container 100 when the device 10 is attachedto the container 100.

The base cap 50 and inner cannula 31 is then attached to theintermediate cap 60. This includes inserting the inner cannula 31through the central opening 62 from the bottom of the cap 60. Insertionpositions the neck 53 of the base cap 50 into the neck 96 of theintermediate cap 60. In one design, one of the slots 54 on the neck 53of the base cap 50 is aligned with the slot 95 on the intermediate cap60. The base cap 50 positioning also locates the bottom edge of the body61 of the intermediate cap 60 against or in proximity to the top edge ofthe intermediate cap 60.

The outer cannula 21 may then be inserted over the inner cannula 31.This insertion includes aligning the proximal end 23 of the outercannula 21 with the distal end 34 of the inner cannula 31 and thensliding the outer cannula 21 over and along the length of the innercannula 31. The fins 27 on the outer cannula 21 slide into the slots 54on the neck 53 of the base cap 50. The outer cannula 21 may be inserteduntil the fins 27 abut against a bottom of the slots 54. This alsolocates the fins 27 at the ramps 63, 64 in the intermediate cap 60.

The top cap 70 is then connected by aligning the distal tip of thedelivery tube 20 with the opening 72. The top cap 70 is then movedrelative to the delivery tube 20 and into contact with the base cap 50.In one design, the bottom edge 94 of the top cap 70 seats within agroove that extends along the outer perimeter of the base cap 50. Thetop cap 70 is positioned with handle 99 on the intermediate cap 60extending through the window 93.

Once assembled, the cap 40 can be attached to the container 100. Thebase cap 50 includes threads that mate with threads on the neck of thecontainer 100. This positions the tube that is attached to the bottom ofthe base cap 50 into the interior of the container 100. This alsopositions the delivery tube 20 extending outward from the cap 40.

FIGS. 12 and 13 illustrate the assembled cap 40 attached to thecontainer 100. The cap 40 is in a first position in FIG. 12 with thehandle 99 positioned at a first end of the window 93. This positionincludes the inner cannula 31 at a first axial position relative to theouter cannula 21. FIG. 13 illustrates a second position with theintermediate cap 60 rotated to a different position with the handle 99at an opposing second end of the window 93. This positions the innercannula 31 at a different axial position relative to the outer cannula21.

Rotation of the intermediate cap 60 relative to the remainder of the cap40 is accomplished by the user grasping and moving the handle 99 to thedifferent rotational positions. Rotation in a first direction causes oneof the fins 27 on the outer cannula 21 to slide along one of the ramps63, 64 on the intermediate cap 60. This sliding movement along the rampcauses relative axial movement with the inner cannula 31. During thesliding movement, the outer cannula 21 is prevented from rotating withthe intermediate cap 60 because the fins 27 are positioned in the slots54 in the neck of the base cap 50. In one specific embodiment, rotationof the intermediate cap 60 in a clockwise rotational direction causes abottom edge of a first fin 27 to slide along a first ramp 63 and movethe outer cannula 21 distally relative to the inner cannula 31. Rotationof the intermediate cap 60 in a counter-clockwise rotational directioncauses a top edge of a second fin 27 to slide along a second ramp 64 andmove the outer cannula 21 proximally relative to the inner cannula 31.

The extent of rotation of the intermediate cap 60 controls the extent ofrelative axial movement between the cannulas 21, 31. In one design,positioning of handle 99 at the first end of the window 93 aligns theoutlets 28, 38 along a first lateral side of the delivery tube 20.Positioning the handle 99 at the second end of the window 93 aligns theoutlets 28, 38 along an opposing second lateral side of the deliverytube. The extent of alignment of the outlets 28, 38 can be controlled bythe user based on the positioning of handle 99 within the window 93. Inone design, positioning the handle 99 at a midpoint along the window 93causes the outlets 28, 38 to be misaligned and for the cap 40 to be in aclosed position to prevent fluid from being expelled. The cap 40 isconfigured for the user to feel the contact between the handle 99 andthe ends of the window 93 to know that the desired position has beenobtained for delivery of the fluid. Further, the user is able tovisually see the positions.

Delivery of the fluid from the container 100 through the delivery tube20 is accomplished by the user squeezing the container 100. Thisdelivery forces the fluid from the container into the tube connected tothe bottom of the base cap 50 and into and through the delivery tube 20.The fluid is then expelled through the outlets 28, 38 that are aligned.Releasing the container 100 causes the container to move back to itsoriginal shape. Air is drawn into the interior of the container throughthe opening 57 in the base cap 50 that is aligned with one or more ofthe openings 97 of the intermediate cap 60.

The cap 40 may also include other designs that provide relative axialmovement between the cannulas 21, 31. One design includes the outercannula 21 being axially movable and rotatable relative to the innercannula 31. Specifically, the outer cannula 21 is threaded onto the neck53 of the base cap 50. The outer cannula 21 includes threads 26 thatextend along the inner surface of the distal end 24 that mate withthreads that extend along the neck 53. Further, the fins 27 of the outercannula 21 are engaged with receptacles 65 in the intermediate cap 60.With the fins 27 engaged in the receptacles, rotation of theintermediate cap 60 in a first direction causes the outer cannula 21 torotate around the neck 53 in a first direction. The threads engagetogether and cause the outer cannula 21 to rotate about the neck 53 andalso move axially relative to the inner cannula 31 in a first direction.The axial movement results in the outlets 28, 38 being aligned andmisaligned as necessary. Likewise, rotation of the intermediate cap 60in the opposing second direction causes the outer cannula 21 to rotateabout the neck 53 in the second direction. This causes the outer cannula21 to both rotate around the inner cannula 31 and move axially relativeto the inner cannula 31. The amount of axial movement and rotation ofthe outer cannula 21 relative to the inner cannula 31 may vary.

The outlets 28 may be separated by different angular placements aroundthe outer cannula 21. FIG. 14A illustrates a schematic end view of theoutlets 28 aligned at different lateral sections around the outercannula 21. The outlets 28 that each includes one or more openings 25are separated by an angle α. FIG. 14A includes an angular placement α ofabout 180° between the outlets 28. FIG. 14B includes an angularplacement α of about 90°. Other designs may include different angularorientations, including a range of 90° and less, and between 90°-180°.

The angular orientations α between the outlets 38 of the inner cannula31 may be the same or different than those of the outlets 28 of theinner cannula 21. In one design, each of the inner and outer cannulas21, 31 includes two outlets 28, 38. Other designs may include a singleoutlet 28, 38 on one or both cannulas 21, 31, or three or more outlets28, 38 on one or both cannulas 21, 31.

Another design for relative axial movement between the cannulas 21, 31includes the user applying a force and moving the outer cannula 21 alongthe inner cannula 31. The cannulas 21, 31 may include stops that controlthe extent of relative axial movement. In one design, the inner cannula31 includes a radial extension that fits within a slot in the outercannula 21. The extension contacts against upper and lower edges of theslot to control the extent of axial movement. In another design, theouter cannula 21 is fixed to the cap 40 and the inner cannula 31 isaxially movable. A radial extension extends outward from the innercannula 31 and extends through a slot in the outer cannula 21. The usergrasps the extension to apply forces to move the inner cannula 31 upwardand downward within the outer cannula 21.

Another design includes each of the intermediate and top caps 60, 70having ramped surfaces. The outer cannula 21 is located such that thefins 27 are positioned between the ramped surfaces. This maintains theouter cannula 21 attached to the cap 40. A biasing member, such as aspring or piece of cushion material, biases the fins 27 against one ofthe ramped surfaces. Rotation of the intermediate cap 60 in a firstdirection causes the fins 27 to slide along one of the ramped surfacesand move the outer cannula 21 axially along the inner cannula 31 in afirst direction. Rotation of the intermediate cap 60 in the opposingsecond direction causes the fins 27 to slide along the other rampedsurface and move the cannula 21 axially in a second direction. In thismanner, the user is able to align the outlets 28, 38 as necessary todirect the fluid.

A delivery device for delivering fluid to the nasal cavity that includescannulas is disclosed in U.S. Patent Publication No. 2016/0228685 whichis hereby incorporated by reference in its entirety.

The embodiments describe the device 10 being attached to a container100, such as a bottle. The device 10 may also be attached to variousother types of containers 100. Examples include but are not limited to ahose and a bag. The various containers 100 may be deformable by the userto force the fluid into the device 10, or may be non-deformable andrequire delivery to the device 10 in other manners such as gravity withthe user tipping the container 100 to move the fluid into the device 10,and a pump that delivers the fluid from the container to the device 10.

A tube may be connected to the device 10 and extend into the container100. Fluid from the container 100 enters into the tube and then entersthe device 10 for delivery to the patient. Other designs do not includea tube, but rather the fluid enters directly from the container 100 intothe device 10.

The various devices 10 may be used during surgical procedures on livingpatients. These may also be used in a non-living situation, such aswithin a cadaver, model, and the like. The non-living situation may befor one or more of testing, training, and demonstration purposes.

Spatially relative terms such as “under”, “below”, “lower”, “over”,“upper”, and the like, are used for ease of description to explain thepositioning of one element relative to a second element. These terms areintended to encompass different orientations of the device in additionto different orientations than those depicted in the figures. Further,terms such as “first”, “second”, and the like, are also used to describevarious elements, regions, sections, etc. and are also not intended tobe limiting. Like terms refer to like elements throughout thedescription.

As used herein, the terms “having”, “containing”, “including”,“comprising” and the like are open ended terms that indicate thepresence of stated elements or features, but do not preclude additionalelements or features. The articles “a”, “an” and “the” are intended toinclude the plural as well as the singular, unless the context clearlyindicates otherwise.

The present invention may be carried out in other specific ways thanthose herein set forth without departing from the scope and essentialcharacteristics of the invention. The present embodiments are,therefore, to be considered in all respects as illustrative and notrestrictive.

1. A device to deliver fluid from a container to a nasal cavity, thedevice comprising: a hollow inner cannula comprising an inlet at aproximal end and first and second outlets positioned towards a distalend with the first and second outlets on different lateral sections, theinlet and the first and second outlets being in fluid-flow relationship;a hollow outer cannula that extends over and houses the inner cannula,the outer cannula comprising third and fourth outlets towards a distalend, the third and fourth outlets on different lateral sections of theouter cannula; and a cap connected to each of the inner and outercannulas and configured to provide relative axial movement of the innerand outer cannulas along a longitudinal axis of the cannulas between afirst axial position and a second axial position; in the first axialposition, the first and third outlets are aligned and the second andfourth outlets are misaligned thereby permitting the fluid to bepredominantly ejected from the third outlet via the first outletrelative to the fourth outlet via the second outlet; in the second axialposition, the first and third outlets are misaligned and the second andfourth outlets are aligned thereby permitting the fluid to bepredominantly ejected from the fourth outlet via the second outletrelative to the third outlet via the first outlet.
 2. The device ofclaim 1, wherein the cap further comprises: a first section that isattached to the proximal end of the inner cannula; and a second sectionthat is rotatable relative to the first section and that includes firstand second ramps that engage with the outer cannula; the first andsecond sections being rotatable relative to each other in a clockwisedirection to slide the outer cannula along the first ramp and move theouter cannula axially relative to the inner cannula in a firstdirection; and the first and second sections being rotatable relative toeach other in a counter-clockwise direction to slide the outer cannulaaxially relative to the inner cannula in an opposing second direction.3. The device of claim 2, wherein the inner cannula is fixedly attachedto the first section of the cap to prevent movement of the inner cannuladuring movement of the outer cannula.
 4. The device of claim 2, furthercomprising fins that extend radially outward from the outer cannula andengage with first and second ramps of the second section.
 5. The deviceof claim 1, wherein each of the first, second, third, and fourth outletscomprise a plurality of openings.
 6. The device of claim 5, wherein thefirst and third outlets comprise a common number of openings and thesecond and fourth outlets comprise a common number of openings.
 7. Thedevice of claim 1, further comprising an opening in the distal end ofeach of the inner and outer cannulas.
 8. A device to deliver fluid froma container to a nasal cavity, the device comprising: a delivery tubecomprising inner and outer cannulas with the inner cannula positionedwithin a hollow interior of the outer cannula, each of the cannulascomprising: an elongated shape with a proximal end and an opposingdistal end; a first outlet towards the distal end and positioned on afirst lateral section; a second outlet towards the distal end andpositioned on a second lateral section; a cap connected to each of theinner and outer cannulas and configured to axially position the innerand outer cannulas relative to one another between a first axialposition and a second axial position; the first axial positioncomprising the first outlets aligned at the first lateral section of thedelivery tube and the second outlets misaligned at the second lateralsection of the delivery tube to deliver the fluid in a first lateraldirection; the second axial position comprising the second outletsaligned at the second lateral section of the delivery tube and the firstoutlets misaligned at the first lateral section of the delivery tube todeliver the fluid in a second lateral direction.
 9. The device of claim8, wherein the proximal ends of each of the inner and outer cannulas areconnected to the cap.
 10. The device of claim 8, wherein one of theinner cannula and the outer cannula are threaded onto a threaded portionof the cap.
 11. The device of claim 8, wherein in the first axialposition the second outlets overlap a lesser amount than the firstoutlets such that a predominant amount of the fluid is ejected from thedelivery tube in the first lateral direction and a lesser amount of thefluid is ejected from the delivery tube in the second lateral direction.12. The device of claim 8, wherein the first outlets and the secondoutlets of each of the inner and outer cannulas are spaced apart aroundthe perimeter of the cannulas by an angle of 90° or less.
 13. The deviceof claim 8, wherein the cap comprises a plurality of members that eachinclude an opening, the members being rotatably connected together andwith the openings coaxially aligned.
 14. The device of claim 8, whereinthe inner cannula is fixedly connected to the cap and the outer cannulais movable relative to the cap, the inner cannula being stationaryduring movement of the outer cannula.
 15. A method of delivering fluidfrom a container to a nasal cavity, the method comprising: rotating afirst cap member in a first rotational direction relative to a secondcap member with a delivery tube comprising an inner cannula and an outercannula being connected to the first and second cap members; relativelymoving the outer cannula relative to the inner cannula in a first axialdirection; aligning a first set of outlets on a first lateral section ofthe inner and outer cannulas and misaligning a second set of outlets ona second lateral side of the inner and outer cannulas, the outlets beingpositioned towards distal ends of the inner and outer cannulas; movingthe fluid from the container into a proximal end of the inner cannula atthe first and second cap members and along the inner cannula andexpelling the fluid through the aligned first set of outlets on thefirst lateral section; rotating the first cap member in a secondrotational direction relative to the second cap member; relativelymoving the outer cannula relative to an inner cannula in an opposingsecond axial direction; aligning the second set of outlets on the secondlateral section of the inner and outer cannulas and misaligning thefirst set of outlets on the first lateral side of the inner and outercannulas; moving the fluid into the proximal end of the inner cannula atthe first and second cap members and along the inner cannula andexpelling the fluid through the aligned second set of outlets on thesecond lateral section.
 16. The method of claim 15, further comprisingpreventing the inner cannula from moving relative to the first andsecond cap members and moving the outer cannula axially along the innercannula.
 17. The method of claim 15, further comprising moving the outercannula relative to the inner cannula in the first and second axialdirections and simultaneously rotating the outer cannula relative to theinner cannula.
 18. The method of claim 15, further comprising expellinga lesser amount of the fluid through the misaligned second set ofoutlets on the second lateral section of the delivery tube whenexpelling the fluid through the aligned first set of outlets on thefirst lateral side.
 19. The method of claim 15, further comprisingmoving a body of the outer cannula over the outlet on the second lateralsection of the inner cannula and preventing the fluid from beingexpelled on the second lateral section when the fluid is being expelledon the first lateral side through the aligned first second of outlets.